Provides oversight and key input for review of new or ongoing safety documents that ensure compliance with domestic and international regulatory requirements, such as clinical protocols, safety summaries, regulatory reports, and submissions packages (CTDs, BLAs, etc.).

Spearheads efforts to further characterize and describe safety issues or potential safety concerns prior to BLA filings, and foresee and help initiate post marketing opportunities for risk mitigation.

Collaborates with medical monitoring professionals and teams that support active clinical trials.

Demonstrates leadership by communicating and collaborating effectively across departments to ensure a company culture that is always committed to putting the safety and well-being of patients first.

Serves as the company’s pharmacovigilance and drug safety subject matter expert in internal and external meetings, including interactions with regulatory agencies.

We seek candidates with the following qualifications:

An advanced medical degree (MD, DO, or equivalent) is preferred.

Must have a proven track record of industry pharmacovigilance experience.

Prior experience with therapeutic biologics is required.

Must have prior experience leading teams.

Must have prior experience with NDA/BLA submissions and new product launch.

Must have experience with developing, implementing, and measuring the impact of pharmacovigilance processes and systems across multiple projects.

Requires proven excellence in operational strategy.

Must have the ability to work within a matrixed team environment.

Must have the ability to interpret, communicate, and present clinical, scientific, and medical information in a clear and concise manner.

Must have demonstrated the ability to proactively and effectively influence peers and external colleagues across all levels of management.

Requires proven negotiation skills.

Must possess a work style that is goal-driven, results-oriented, and committed to high quality.

If interested, please email your resume as a Word attachment to us, reference 3673. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.